Ozurdex for Diabetic Macular Edema Treated With Pars Plana vitrEctomy and Membrane RemovAl (OPERA Study)

NCT01613716 | Completed Phase 4 Results DMC

• 1 other identifier: 115200
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the use of the dexamethasone implant (Ozurdex) in patients with macular edema associated with an epiretinal or preretinal membrane requiring surgical intervention. After the surgery is performed (pars plana vitrectomy), an Ozurdex implant will be placed in the eye. Patients will be followed for 1 year.

Conditions

Diabetic Macular Edema; Epiretinal Membrane

Keywords

Diabetes; Macular Edema; Epiretinal Membrane; Vitrectomy

Outcome Measures

Primary Outcomes (2)

• Central Retinal Thickness

  At 3 months, central retinal thickness as measured by optical coherence tomography will be measured

  3 months

• Visual Acuity

  ETDRS visual acuity will be measured at 3 months. Visual function of the study eye was assessed using the ETDRS protocol, which is a widely accepted international standard. A higher letter score represents better functioning.

  3 months

Study Arms (1)

Ozurdex

EXPERIMENTAL

Subjects will receive Ozurdex injections and will be monitored for macular edema.

Drug: Ozurdex

Interventions

Ozurdex DRUG

Ozurdex .7 mg injected into the treated eye

Also known as: Dexamethasone

Ozurdex

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are undergoing pars plana vitrectomy for:
• Epiretinal membrane/vitreomacular traction or
• Diabetic macular edema
• Patients with macular edema as measured by OCT (at least 250 um central subfoveal thickness)
• Informed consent requirements: All study subjects must agree to participate in the study and provide written informed consent, which will be written in English.
• Age between 18-85 years old

You may not qualify if:

• Age \< 18 years or \> 85 years
• History of active inflammatory eye disease (uveitis) (within 3 months)
• History of ocular malignancy and/or ocular/orbital irradiation
• History of recent retinal vein occlusion (within 6 months)
• History of neovascular age-related macular degeneration or choroidal neovascular membrane \[
• History of juxtafoveal telangiectasia
• History of Coat's disease
• History central serous choroidoretinopathy
• History of previous infectious retinitis (toxoplasmosis, acute retinal necrosis, tuberculosis, etc)
• Patients with a history of intraocular infection in the study eye (i.e. viral retinitis, endophthalmitis)
• Patients who are cognitively impaired or those who are unable to provide informed written consent
• Patients with a history of glaucoma in the study eye (defined as increased cup to disc ratio with associated nerve damage. Patients with ocular hypertension controlled by topical glaucoma drops (maximum 3) will not be excluded).
• Patient with recent intravitreal injections of steroids or anti-VEGF medications in the study eye (within past 4 weeks).
• Patients with recent periocular steroid injection (within past 4 weeks) in the study eye
• Patients on topical NSAIDS drops (patient will be eligible if they discontinue use of topical NSAIDs at time of study enrollment) in the study eye

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Allergan: collaborator

Study Sites (1)

Cole Eye Institute, Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Epiretinal Membrane; Diabetes Mellitus; Macular Edema

Interventions

Calcium Dobesilate; Dexamethasone

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Macular Degeneration; Retinal Degeneration

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Sunil K. Srivastava, MD
• Organization: Cleveland Clinic Foundation

srivass2@ccf.org

216-636-2286

Study Officials

• Sunil Srivastava, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: June 5, 2012
• First Posted: June 7, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: February 1, 2017
• Last Updated: May 16, 2018
• Results First Posted: May 16, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)